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Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

NCT02422927 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-04-22

No results posted yet for this study

Summary

The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).

Conditions

Interventions

DIETARY_SUPPLEMENT

Nutraceutical Combination

red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily

OTHER

Standard of Care

low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule

OTHER

Placebo

placebo

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Principal Investigators

  • Matteo Pirro, MD, PhD · University Of Perugia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-01-31
Completion
2015-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02422927 on ClinicalTrials.gov